Sofosbuvir plus ledispasvir for recurrent hepatitis C in liver transplant recipients

Abstract

Hepatitis C virus (HCV) recurrence after liver transplantation (LT) is associated with worse outcomes. The combination of ledipasvir (LDV) and sofosbuvir (SOF) has been approved for HCV treatment after LT, but there are limited data on the effectiveness and safety of LDV/SOF in the "real-world" setting. This multicenter study is the largest report to date on the effectiveness and safety of LDV/SOF in the post-LT setting. A total of 204 patients (72% male, 68% Caucasian, 66% genotype [GT] 1a, 21% METAVIR F3-F4, 49% treatment-experienced) were treated with LDV/SOF. The mean duration from LT to treatment initiation was 4.8 years. The overall sustained virological response rate 12 weeks after completion of therapy (SVR12) was 96%. Patients treated with 8 or 12 weeks of LDV/SOF without RBV experienced an SVR12 rate of 100% and 96%, respectively. Calcineurin inhibitors were used in 89% of patients, and 32% of patients underwent adjustment in immunosuppression during treatment. One episode of mild rejection, responsive to an increase in immunosuppression dosage, was observed. There was no graft loss attributed to HCV treatment. Four deaths occurred unrelated to HCV treatment, and no significant serious adverse events were documented. In conclusion, SOF and LDV with or without RBV for 8, 12, or 24 weeks in post-LT patients was effective and safe with a high SVR12 rate across a spectrum of GTs and stages of fibrosis. Liver Transplantation 22 1536-1543 2016 AASLD.

Use of direct antiviral agents in liver transplant recipients with hepatitis C virus in Korea: 2-center experience

“…We observed a remarkable SVR12 of 100% for pretransplant use and SVR12 of 94% for post-transplant use. Our results are comparable to previously reported rates in practice [101112]. The combination of DAAs was well tolerated with a low rate of adverse events.…”

“…Real-world studies have supported high SVR rates and excellent tolerability of DAA regimens in LT recipients with recurrent hepatitis C and mild to moderate fibrosis including combination regimens of SOF/LDV and SOF plus DCV [1011121516]. …”

“…Because of hematologic abnormalities associated with RBV, a RBV-free regimen may be considered effective. Limited real-world experiences with SOF-based therapy without RBV suggest similar SVR rates to an RBV-containing regimen [101115]. Avoidance of ribavirin is desirable given the reduction in renal perfusion after liver transplantation due to the use of calcineurin inhibitors and reduced hemoglobin levels.…”

“…Since the introduction of DAA agents, multiple non-IFN regimens represent an important achievement in HCV treatment, with higher rates of HCV cure and fewer adverse events [7891011]. Three recent observational studies using sofosbuvir-based therapy reported 100% SVR12 rates after completion of therapy [101112].…”

“…Three recent observational studies using sofosbuvir-based therapy reported 100% SVR12 rates after completion of therapy [101112]. However, limited data are available on the efficacy and safety of DAAs in liver recipients in Asia.…”